1. Technical Field
This invention relates to a medical device and, in particular, a prosthesis for implantation within the human or animal body for the repair of an aneurism, dissection, or intramural hematoma within a lumen, and a method for implanting the same.
2. Related Art
Throughout this specification, when discussing the aorta or other blood vessels, the terms distal and distally with respect to a prosthesis are intended to refer to the end of the prosthesis furthest away in the direction of blood flow from the heart. Similarly, the terms proximal and proximally are intended to mean the end of the prosthesis which, when implanted, would be nearest to the heart.
The functional vessels of humans, such as blood vessels and ducts, occasionally weaken or even rupture. For example, the aortic wall can weaken, resulting in an aneurysm Upon further exposure to haemodynamic forces, such an aneurysm can rupture. A common surgical intervention for weakened, aneurismal or ruptured vessels is the use of a prosthesis to provide some or all of the functionality of the original, healthy vessel and/or preserve any remaining vascular integrity by replacing a length of the existing vessel wall that spans the site of vessel failure.
The deployment of intraluminal prostheses into the lumen of a patient from a remote location by the use of a deployment device or introducer has been disclosed in a number of earlier patents, published patent applications, and other publications. U.S. Pat. No. 4,562,596, entitled “Aortic Graft, Device and Method for Performing an Intraluminal Abdominal Aortic Aneurysm Repair” which is herein incorporated by reference, proposes the retention of a self expanding graft within a sleeve until it is to be deployed, at which time the sleeve is withdrawn and the graft is allowed to expand. U.S. Pat. No. 4,665,918, entitled “Prosthesis System and Method” which is herein incorporated by reference, proposes a system and method for the deployment of a prosthesis in a blood vessel. The prosthesis is positioned between a delivery catheter and an outer sheath and expands outwardly upon removal of the sheath.
U.S. Pat. No. 4,950,227, entitled “Stent Delivery System” which is herein incorporated by reference, proposes the delivery of a stent by mounting the stent to the outside of an inflatable catheter and retaining the ends of an unexpanded stent by fitting a sleeve over either end of the stent. Expansion of the stent is caused by inflation of the catheter between the sleeves so that the ends of the stent are withdrawn from the respective sleeves and the stent released and expanded into position.
Other clinical approaches to aneurysm repair known as endovascular grafting have been proposed. (See, Parodi, J. C., et al. “Transfemoral Intraluminal Graft Implantation for Abdominal Aortic Aneurysms,” 5 Annals of Vascular Surgery, 491 (1991)). Endovascular grafting involves the transluminal placement of a prosthetic arterial graft in the endoluminal position within the lumen of the artery. By this method, the graft is attached to the internal surface of an arterial wall by means of attachment devices such as expandable stents, a cephalic stent above the aneurysm and a caudal stent below the aneurysm.
U.S. Pat. No. 5,387,235 entitled “Expandable Transluminal Graft Prosthesis for Repair of Aneurysm”, discloses apparatus and methods of retaining grafts onto deployment devices. These features and other features disclosed in U.S. Pat. No. 5,387,235 could be used with the present invention and the disclosure of U.S. Pat. No. 5,387,235 is herein incorporated by reference.
U.S. Pat. No. 5,720,776 entitled “Barb And Expandable Transluminal Graft Prostheses for Repair of Aneurysm” discloses improved barbs with various forms of mechanical attachment to a stent. These features and other features disclosed in U.S. Pat. No. 5,720,776 could be used with the present invention and the disclosure of U.S. Pat. No. 5,720,776 is herein incorporated by reference.
U.S. Pat. No. 6,206,931 entitled “Graft Prosthesis Materials” discloses graft prosthesis materials and a method for implanting, transplanting replacing and repairing a part of a patient and particularly the manufacture and use of a purified, collagen based matrix structure removed from a submucosa tissue source. These features and other features disclosed in U.S. Pat. No. 6,206,931 could be used with the present invention and the disclosure of U.S. Pat. No. 6,206,931 is herein incorporated by reference.
PCT Patent Publication Number No. WO99/29262 entitled “Endoluminal Aortic Stents” discloses a fenestrated prosthesis for placement where there are intersecting arteries. This feature and other features disclosed in PCT Patent Publication Number No. WO99/29262 could be used with the present invention and the disclosure of PCT Patent Publication Number No. WO99/29262 is herein incorporated by reference.
PCT Patent Publication Number No. WO03/034948 entitled “Prostheses for Curved Lumens” discloses prostheses with arrangements for bending the prosthesis for placement into curved lumens. This feature and other features disclosed in PCT Patent Publication Number No. WO03/034948 could be used with the present invention and the disclosure of PCT Patent Publication Number No. WO03/034948 is herein incorporated by reference.
United States Patent Application Publication No. 20030233140 entitled “Trigger Wire System” discloses release wire systems for the release of stent grafts retained on introducer devices. This feature and other features disclosed in United States Patent Application Publication No. 20030233140 could be used with the present invention and the disclosure of United States Patent Application Publication No. 20030233140 is herein incorporated by reference.
United States Patent Application Publication No. 20040098079 entitled “Thoracic Aortic Stent Graft Deployment Device” discloses introducer devices adapted for deployment of stent grafts particularly in the thoracic arch. This feature and other features disclosed in United States Patent Publication No. 20040098079 could be used with the present invention and the disclosure of United States Patent Publication No. 20040098079 is herein incorporated by reference.
United States Patent Application Publication No. 20040054396 entitled “Stent-Graft Fastening” discloses arrangements for fastening stents onto grafts particularly for exposed stents. This feature and other features disclosed in United States Patent Application Publication No. 20040054396 could be used with the present invention and the disclosure of United States Patent Application Publication No. 20040054396 is herein incorporated by reference.
PCT Patent Publication Number No. WO03/053287 entitled “Stent Graft With Improved Graft Adhesion” discloses arrangements on stent grafts for enhancing the adhesion of such stent grafts into walls of vessels in which they are deployed. This feature and other features disclosed in PCT Patent Publication Number No. WO03/053287 could be used with the present invention and the disclosure of PCT Patent Publication Number No. WO03/053287 is herein incorporated by reference.
PCT Patent Publication Number No. WO98/53761 entitled “A Prosthesis and a Method of Deploying a Prosthesis”, which is herein incorporated by reference, discloses various embodiments of an introducer for positioning an expandable endovascular prosthesis in a lumen of a patient.
One issue that arises with the use of an intraluminal prosthesis is where the damage in a vessel is at or near an angled or curved portion of the lumen, such as, for example, the aortic arch. In these instances, the intraluminal prosthesis may have an increased tendency to leak. It would be desirable to provide an intraluminal prosthesis with a sealing means that provides an effective seal in an angled or curved portion of a lumen.